August Bioservices
Quality Assurance Lead
Nashville, Tennessee
Sponsorship not specifiedDetected 1610 days ago
GMPFDA Regulatory
About the role
- Headquartered in Nashville, TN - one of the fastest-growing and most exciting cities in the United States - August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO).
- The Quality Assurance Operations, Quality Assurance is responsible for supporting Quality Assurance Operations at August Bioservices.
- This role will interact with all levels of the company in a fast paced and growing environment.
Responsibilities
- Implement, coordinate, administer, and continuously improve the Quality Assurance AQL Visual Inspection / On-The-Floor program:
- Partners with manufacturing and other internal groups to establish a philosophy for visual inspection and develops the visual inspection qualification for operators and QA AQL Specialists.
- Builds and maintains qualification kits.
- Collaborates with manufacturing to develop the program for classification of rejects and AQL levels.
- Participates in equipment design and start-up of automated equipment and manual/semi-manual visual inspection start up.
- Supports implementation / qualification of automated inspection procedures.
- Develops QA documents for visual inspection AQL inspection.
- Ensure regular presence in operational areas and support personnel on quality matters.
- Ability to assess and triage deviations that occur with the local process team. Write, review, and assess deviations, and participate in investigations. Support CAPAs, gap analysis, and product complaints.
- Provide support during internal / external / regulatory inspections.
Requirements
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Ability to safely wear and work in a PAPR hood and associated equipment weighing approximately 2 to 3 pounds during assigned tasks.
- Ability to wear and operate a Powered Air-Purifying Respirator (PAPR) for extended periods, up to 4 to 6 hours per shift, while performing manufacturing, equipment cleaning, and sanitization activities.
- Ability to wear required PPE, including pharmaceutical gowning, respiratory protection, safety glasses, chemical-resistant gloves, and additional protective equipment as required by operational and safety procedures.
- Completes training and maintains required qualifications for visual inspections.
- Also ensures that the schedule is being monitored and operations has all the required releases to ensure no downtime.
Nice to have
- responsible and engaged citizens within our communities
- and active, mindful stewards of our environment.
Benefits
- For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August!
- Ensures appropriate coverage which may include some evenings.
Company info
- At August Bioservices, Our Credo is our culture.
- We are committed to doing the right thing the first time and every time, meeting or exceeding all regulatory requirements.
- We are August Bioservices.
- We are pointing the way forward.
Equal opportunity
- ADA Accommodation Notice
- August Bioservices is an equal opportunity employer and values diversity.
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This listing is sourced directly from August Bioservices's careers page and normalized into a canonical job model.